Insights
Patent and Trademark Office Implements Service by Publication Procedure
There previously used to be delays in the notifi cation of documents to applicants due to their failure to inform the offi ce ofaddress changes A provision was added to the IP Code in order to fi nd a solution to the issue of serving documents to rights holders All documents that could not be served due to an address change have now started to be served via publication through an Official Bulletin In the past, there used to be delays in the notifi cation of documents to… »
Medical Devices: Draft Communiqué on Instructions For Use in Electronic Form Published
On 30 May 2022, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) on its official website, stating that a draft Communiqué on the Instructions for Use in Electronic Form for Medical Devices (Draft) has been prepared and asked stakeholders to provide feedback on the Draft. As part of Turkey's alignment process with EU law, the Draft has been prepared in accordance with Commission Implementing Regulation (EU) 2021/2226 laying… »
Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses Published
On 15 June 2022, the Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses (Turkish language) (Regulation) was published in the Official Gazette numbered 31867. The Regulation abrogated the prior regulation dated 20 October 1999 and is now in line with Directive 2001/83/EC on medicinal products for human use. Pharmaceutical warehouses are defined as establishments where one or all of the activities of procurement, storage, sale… »
SSI Publishes Amendment to the Alternative Reimbursement Regulation Upon Annulment of the State Council
In the cancellation action filed by the Turkish Pharmacist Union against some of the provisions of the Alternative Reimbursement Regulation (“Regulation”), the 10th Chamber of the Council of State decided to annul the attacked provisions of the Regulation on the ground that the Regulation was issued by the Social Security Institute (“SSI”) without obtaining prior opinion of the Ministry of Health. Upon the service of the court decision to SSI, due to the requirement to comply… »
Neither a Compulsory License nor an IP Waiver is the Solution to Finding or Accessing the Vaccine
Since the pandemic seems to lose its impact and life is going back to normal, it may be a good time to look into the lessons learned so far from Covid 19 pandemic and make necessary preparations against a possible new one. The pandemic brought many discussions on IP rights from day one. As we all know, compulsory licensing was the first solution mechanism depended on by the governments as it was thought that the existing patent rights were the only obstacle to reaching a cure… »
COVID-19: Guideline on Risk Management Plans for Vaccines Published
On 24 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guideline on Essential Requirements for Risk Management Plans of COVID-19 Vaccines (Turkish language). The guideline is prepared as an attachment to Module IV of the Guideline on Good Pharmacovigilance Practices. The guideline aims to provide detailed explanations on the procedures and requirements that marketing authorisation holders should complete for… »
New Regulation Regarding the Use of Consumer Reviews
Consumer reviews have become an important part of the advertising ecosystem. These reviews are very influential to potential customers when they are making a purchasing decision. Marketers use reviews in advertising, they host reviews on their websites, they encourage consumers to post reviews on other sites, and some even try to prevent customers from posting negative reviews at all. Although consumer reviews have such a significant impact, the Turkish Law did not have a… »
Registrability of 3D Trademarks
The Turkish Court of Cassation (the CoC) issued a decision in which the registrability of a 3D medical device trade mark is discussed. This paper aims to provide the details of the matter and to remark upon its importance. Background A 3D device trade mark application covering goods in classes 5 and 10 was filed before the Turkish Patent and Trademark Office (the Office) and was rejected as the Office found the application as non-distinctive and descriptive. Court Phases The… »
Effective Date of Additional Obligations on Consumer Protection Approaches
The Law No. 7392, published in the Official Gazette numbered 31796 on April 1, 2022, has introduced significant changes to many issues regulated under the Consumer Protection Law (the “Law”). The provisions of the new law that relate to timeshare and long-term vacation agreements entered into force on April 1, 2022, before the summer season. However, most of the changes, including those below, will come into effect on October 1, 2022. As the changes are substantial, we… »
Explicit Consent under The Data Protection Law
Explicit consent has been defined as consent that relates to a specified issue, declared by free will, and based on information. The definition provides that not all kinds of consent will suffice under the Data Protection Law. The data subject must know for what s/he is giving consent and must clearly express his/her consent. For example, consent obtained in English from non-English speakers in Turkey would not be considered to be explicit consent. Further, implied consent is… »
Recent Developments on Using Personal Data Unlawfully Collected as Evidence
According to Article 38 of the Turkish Constitution, findings that are acquired unlawfully cannot be used as evidence. In this respect, using personal data as evidence in disputes requires a legal assessment on whether the personal data is collected lawfully or not. In principle, evidence that are obtained unlawfully shall not be allowed in legal proceedings. As known, the main legislation related to protection of personal data is the Turkish Personal Data Protection Law No.… »
Making Payments in Turkish Lira in Movable Sale Contracts Has Become Mandatory
Former Regulations Concerning FX Prohibition The Presidential Executive Decree numbered 85 and dated 12 September 2018 (the “Decree”) prohibits the private and public residents in Turkey from agreeing their payment obligations in or indexed to foreign currencies in contracts between them concerning sale and purchase of movable and immovable, all kinds of lease and rentals of movables or immovable including vehicle leases and financial leases, employment, service and… »